Three Countries, Three Continents: AI Medical Device Regulation and Certification Comparison in the US, EU, and South Korea

Kanjar De, Alireza Salehi M.

Keywords: Artificial Intelligence, Medical Devices Regulation, EU AI Act, EU MDR, EU IVDR, Risk based Regulation

TL;DR: Study compares AI medical device certification across US, EU, South Korea, revealing different strategies—adaptive, dual regulatory, incentivized—complicate global compliance.

Abstract: The rapid integration of artificial intelligence into medical devices has created unprecedented regulatory challenges, requiring novel certification frameworks that balance innovation with patient safety across major global markets. This paper provides a comparative analysis of AI medical device certification pathways in three leading jurisdictions: the United States (FDA), European Union (AI Act and MDR/IVDR), and South Korea (Medical Devices Act), examining risk classification systems, approval processes, and post-market requirements through systematic review of regulatory frameworks and guidance documents. Although all jurisdictions adopt risk-based approaches, implementation strategies vary significantly. The FDA emphasizes adaptive frameworks with predetermined change control plans, the EU combines horizontal AI Act requirements with sector-specific medical device regulations, and South Korea introduces novel high-impact AI provisions with incentivized impact assessments for medical applications. These regulatory differences create complex compliance landscapes for global manufacturers, making understanding of jurisdiction-specific pathways essential for strategic market entry and product development. The analysis in this paper provides actionable insights for optimizing certification strategies while ensuring patient safety across these critical markets.

Submission Number: 5